PARIS--(BUSINESS WIRE)--May 18, 2011 Six-month results from the
BIOSOLVE-I first-in-man (FIM) trial, studying the
DRug-Eluting Absorbable Metal
Scaffold (DREAMS), demonstrate a high safety profile of the
novel device. For the first cohort of 22 patients, there was no
cardiac death, no target vessel myocardial infarction (MI) and no
stent thrombosis, as presented at the European Conference of Paris
Course on Revascularization (EuroPCR) by Professor Michael Haude,
Lukas Hospital, Neuss, Germany, one of the investigators of the
study.

The BIOSOLVE-I study is a prospective, multicenter,
nonrandomized, European, FIM trial evaluating the safety and
efficacy of DREAMS. The primary endpoint is target lesion failure
(TLF) at 6 months for cohort 1 and at 12 months for cohort 2. Major
secondary endpoints are cumulative major adverse coronary event
rates at 1 month, 6 months and 12 months, as well as at 2
years and 3 years; in-scaffold and in-segment late luminal loss are
measured at 6- and 12-month follow-ups. In addition to the
quantitative coronary angiography (QCA) follow-up, intravascular
ultrasound (IVUS) and optical coherence tomography (OCT) imaging
are performed at 6 months and 12 months. Vasomotion assessment is
completed at the same time points.

Between July and December 2010, 47 DREAMS were implanted in 46
patients. The 6-month outcomes reveal two cases of target lesion
failure (9.1%) reflected only by clinically driven target lesion
revascularization. The angiographic in-scaffold late lumen loss
outcome is 0.68 mm.

“These outcomes demonstrate a considerable improvement
over the bare version of the absorbable metal scaffold and confirm
that the development strategy is taking the right direction,”
commented Professor Haude.

Professor Haude also highlighted the superior mechanical
properties of the DREAMS scaffold compared with absorbable
scaffolds made of polymeric materials. “DREAMS' expansion
behavior is very similar to a permanent metallic stent,” he
reported. “Also, its appearance in OCT at the baseline
procedure looks like a permanent metallic stent.”

The drug-eluting absorbable metal scaffold is part of a
revolutionary new treatment option for patients with coronary
artery disease. In contrast to existing permanent stents, this
device, based on an absorbable magnesium backbone, degrades over
time and leaves nothing behind but a healed vessel that can resume
its natural functionality.

DREAMS is made of a proprietary magnesium alloy coated with a
matrix of a degradable polymer and paclitaxel to inhibit neointimal
cell proliferation within the first few months after scaffold
implantation. DREAMS, a novel treatment concept designed to
eliminate the long-term risks associated with a permanent implant,
opens a new area of vascular restoration therapy.

“Looking at the results of the first cohort only, the
outcomes of DREAMS confirm a very good safety profile of the
absorbable scaffold. While we believe that 6-month outcomes
indicate a tendency, longer follow-up periods are necessary before
we would draw confident conclusions about this novel
therapy,” stated Alain Aimonetti, Vice President Marketing
and Sales with BIOTRONIK. “As we have previously seen with
vascular restoration therapy, 12-month results play an important
role after proper healing and remodeling of the vessels.”

More OCT and IVUS results are expected to be presented at TCT
2011. For more information about the BIOTRONIK portfolio, visit
www.biotronik.com.

About BIOTRONIK

As one of the world's leading cardiovascular medical device
companies, with several million implanted devices, BIOTRONIK is
represented in over 100 countries with its global workforce of more
than 5,600 employees. Known for having its fingers on the pulse of
the medical community, BIOTRONIK assesses the challenges physicians
face and provides the best solutions for all phases of patient
care, ranging from diagnosis and treatment to patient management.
Quality, innovation and clinical excellence define BIOTRONIK and
its growing success—and deliver confidence and peace of mind
to physicians and their patients worldwide.

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